Chief, Research Oversight & Compliance
Clinical Research Management - Dayton, OH

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Growing and well-respected biomedical (clinical, basic and applied) research firm has job opportunities at Wright Patterson Air Force Base. If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.

We are currently seeking a Chief, Research Oversight & Compliance for the Dayton, Ohio area.

RESPONSIBILITIES:

  • The Chief, ROC, shall support and coordinate internal and external audits of all human research projects.
  • Provide guidance and recommendations (of a non ‐ inherently government nature) for any internal audits of human research studies to ensure all appropriate regulations are followed.
  • Coordinate and support external audits of any human research projects. Facilitate regular audits of all IRB ‐ approved research studies, and ensure findings are appropriately documented and any deficiencies adequately addressed.
  • Review and ensure that new research applications related to human clinical investigations/research are in compliance with federal and state regulations as well as institutional guidelines prior to IRB review.
  • Work with the IRB Administrator, the Research Protocol Coordinator, and Principal Investigators (PIs) to ensure that research applications are complete.
  • Communicate with PIs regarding any items requiring clarification prior to IRB review.
  • Upon receipt of human research protocol submissions, review for completeness, compliance with federal and state regulations as well as institutional guidelines, make recommendations for IRB review assignments, and forward to the IRB Chair.
  • Ensure that Informed Consent Documents (ICDs) contain required content as per the submitted protocol and subsequent amendments as well as meet federally mandated requirements.
  • Provide written correspondence to PIs communicating the outcome of the research application by the IRB. Note: the IRB is comprised of Government representatives.
  • Serve as in ‐ house advisor to administration and researchers regarding DoDI 3216.02, AFI 40 ‐ 401 issues relating to protection of human subjects and adherence to ethical standards in DoD ‐ sponsored research.
  • Perform initial and supplementary ethics and legal reviews of research applications for exempt and non ‐ exempt review.
  • Support initial legal review of site specific CRADAs and invention disclosures.
  • Support ongoing compliance and management of program audits of sponsored research programs.
  • Evaluate reports of unanticipated problems, protocol amendments and continuing review forms, and prepare recommendations to the IRB committee.
  • Report serious noncompliance issues to the IRB Director (a Government representative).
  • Coordinate a team approach to produce the monthly IRB agenda for each meeting and help ensure that materials are distributed within established guidelines.
  • Work with other members of the team, attend IRB meetings, ensure deliberations are recorded and meeting minutes are documented for IRB Chair approval.
  • Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.
  • Assist with training and orientation tasks of new committee members.
  • Provide guidance (but not supervision), and serve as a resource, to co ‐ workers in the IRB office.
  • Monitor the regulatory environment and recommend changes, as needed, to institutional officials.
  • Shall provide guidance and oversight of an electronic IRB system when implemented.
  • Coordinate appropriate training to implement and maintain an electronic IRB system.
  • Manage the day to day maintenance of an electronic IRB system.
  • Facilitate uploading all appropriate documents and files to an electronic IRB system.
  • Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment.
  • Work collaboratively with the IRB Chair to facilitate ongoing development, implementation and maintenance of the human subject’s protection program.
  • Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
  • Performs light duties and other related duties as required and assigned.


  • MINIMUM QUALIFICATIONS:

  • BA or BS degree in a biomedical field with a minimum of 3 years experience in research administration in support of clinical/biomedical research and/or IRB experience in a health care environment. Master’s Degree desired.
  • Knowledge and experience with electronic IRB processes is preferred.
  • Previous managerial/supervisory experience with demonstrated success in leading and managing people is required. Strong leadership and team building skills and experience working collaboratively to motivate others are highly essential.
  • Must have and maintain a Certified IRB Professional (CIP) or Certified IRB Manager (CIM) certificate upon meeting eligibility criteria. This certification must be a valid, unrestricted, and current certification.
  • Possess and maintain current certification in Basic Life Support (BLS).
  • Experience with Air Force (or military service) specific human clinical research protocols and guidelines.
  • Knowledge of and experience with IRB policies regarding human experimentation, emergency protocols, and adverse events.
  • Knowledge of Medical Treatment Facility (MTF) Infection Control and Employee Health Programs.
  • Knowledge and experience in the interpretation of Federal and State regulations particularly regarding the protection of human subjects in biomedical research (to include working knowledge of Federal regulations for human research: 21 CFR parts 50, 56, 312, and 812; and 45, CRF 46).
  • Ability to advise and counsel on matters of general research compliance and ethical research practices.
  • Experience with human protection exempt and non exempt experimentation forms including research proposal, informed consent, HIPAA, and de-identification agreements.
  • Experience with Federal Wide Assurance, Air Force (or military service) Assurance and Air Force (or military service) addendums.
  • Experience with Air Force (or military service) Individual Investigator and Institutional agreement documentation process.
  • Experience in designing, operating and implementing electronic IRB applications.
  • Ability to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities.
  • Thorough knowledge of 10 USC 980 application and management requirements.
  • Thorough knowledge of incidental findings ethical issues.
  • Experience with FDA Investigational Device Exemptions and Investigational New Drug policies and submissions.
  • Experience with DoD vendor contract negotiation and review.
  • Thorough knowledge of DoD, DHHS and FDA Federal database and specimen repository creation and management policies.
  • Must be able to work independently following a brief period of specific technical training.


  • Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

    ClinicalRM is an Affirmative Action-Equal Opportunity Employer

    www.clinicalrm.com

    “NorthCoast 99” Best Places to Work recipient

    About this company
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    ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.